Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

JFord Speculum Sleeve™

K-Number: K252208 · 2026-03-06

ApplicantFord Medtech, LLC
Decision Date2026-03-06
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

JFord Speculum Sleeve™ is the device name listed in this FDA 510(k) record. The listed applicant is Ford Medtech, LLC. It received FDA 510(k) clearance on 2026-03-06 under 510(k) number K252208. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JFord Speculum Sleeve™?

JFord Speculum Sleeve™ is a medical device that received FDA 510(k) clearance on 2026-03-06. The listed applicant is Ford Medtech, LLC. The 510(k) number is K252208.

When did JFord Speculum Sleeve™ receive FDA 510(k) clearance?

JFord Speculum Sleeve™ received FDA 510(k) clearance on 2026-03-06, under 510(k) number K252208.

Who is the listed applicant for JFord Speculum Sleeve™?

The FDA 510(k) record lists Ford Medtech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JFord Speculum Sleeve™?

The FDA product code for JFord Speculum Sleeve™ is HIB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Related Devices (Code: HIB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130046CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLCK120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.K110766KOLPLUX SYSTEMKolplast CI LtdaK092870NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMObp CorporationK072942MEDLINE DISPOSABLE VAGINAL SPECULUMMedline Industries, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑